BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY AUTOCODE

    MDR report key: 10827580 · Received November 12, 2020

    Report

    Report Number
    3005862821-2020-00061
    Event Type
    Injury
    Date Received
    November 12, 2020
    Date of Event
    October 9, 2020
    Report Date
    October 30, 2020
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    NBW
    UDI-DI
    00384841518505
    PMA / PMN Number
    K073118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO NON-CONFORMANCE WAS FOUND AFTER OKB REVIEWED ALL MANUFACTURING, AND QC RECORDS OF THE SUSPECTED DEVICE (METER SERIAL#: (B)(4) AND STRIP LOT#: D190529-2). RETURN AND RETAINED STRIPS (LOT#: D190529-2) WERE RE-TESTED BY USING RETURN METER (SERIAL#: (B)(4)) AND RETAINED METER (SERIAL#: (B)(4)) WITH CONTROL SOLUTIONS (LEVEL LOW: BATCH# 9AH1A99, EXP. BY FEB., 2022; LEVEL HIGH: BATCH# 9AH3A16, EXP. BY JAN., 2022), RESPECTIVELY, AND RESULTS AS BELOW MET THE ACCEPTANCE CRITERIA (LEVEL LOW: 40~90 ; LEVEL HIGH: 220~330). RETURN METER W/ RETURN STRIPS: 67 (LEVEL LOW) AND 286 (LEVEL HIGH). RETURN METER W/ RETAINED STRIPS: 73/75 (LEVEL LOW) AND 268/287 (LEVEL HIGH). RETAINED METER W/ RETURN STRIPS: 67 (LEVEL LOW) AND 266 (LEVEL HIGH) . RETAINED METER W/ RETAINED STRIPS: 74/75 (LEVEL LOW) AND 275/275 (LEVEL HIGH). METER SETTING AND ALL FUNCTIONS OF THE SUSPECTED DEVICE WERE RE-TESTED, AND ALL OF THEM WERE OPERATED PROPERLY. STANDBY CURRENT OF THE DEVICE WAS RE-CHECKED AND THE CURRENT (1.8 UA) MET ACCEPTANCE CRITERIA (< 55 UA). AS ABOVE, NO NON-CONFORMANCE AND MALFUNCTION OF THE SUSPECTED DEVICE WERE FOUND. THE ROOT CAUSE OF THE COMPLAINT WAS UNABLE TO BE VERIFIED WITHOUT MORE USERS' INFORMATION. THEREFORE, THE COMPLAINT HAD TO BE CLOSED OUT IF NO FURTHER ACTION FROM THE USER.

    Description of Event or Problem · 1

    CALLER STATED THAT, "MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2020, AROUND 3:00PM, AT HOME. CALLER STATED THAT HE TESTED THE END-USER WITH HIS PRODIGY METER, AND RECEIVED A RESULT OF HI. CALLER STATED THAT THE END-USER DOES NOT HAVE A NORMAL RANGE FOR HIS BLOOD GLUCOSE DUE TO IT FLUCTUATING. CALLER STATED THAT HE GAVE THE END-USER 8 UNITS OF INSULIN. HE WAS UNSURE WHICH INSULIN HE GAVE, TESTED AGAIN WITH THE PRODIGY METER, AND GOT ANOTHER RESULT OF HI. CALLER STATED THAT THE END-USER WASN'T SHOWING ANY SYMPTOMS OF HAVING A HIGH BLOOD GLUCOSE, AND STATED THAT HE FELT FINE, BUT HE GAVE HIM ANOTHER 10 UNITS OF INSULIN. HE THEN TESTED THE END-USER AGAIN WITH HIS PRODIGY METER, AND RECEIVED ANOTHER RESULT OF HI. CALLER STATED HE THEN CALLED PARAMEDICS APPROXIMATELY 5 MINUTES AFTER TESTING. THE PARAMEDICS ARRIVED WITHIN 3 MINUTES, TESTED THE END-USER WITH THEIR METER, AND RECEIVED A RESULT OF 245MG/DL. PARAMEDICS; GAVE NO TREATMENT, AND DID NOT TRANSPORT THE END-USER TO THE HOSPITAL. PARAMEDICS. ADVISED THE CALLER, AND END-USER TO TAKE INSULIN BASED ON THE END-USERS SLIDING SCALE. CALLER STATED THAT HE DID NOT KNOW WHAT THE SLIDING SCALE WAS NOR, DID HE KNOW ALL THE MEDICATION THE END-USER IS PRESCRIBED ONLY HIS INSULIN. PARAMEDICS DID NOT CHECK THE END-USERS BLOOD GLUCOSE BEFORE LEAVING. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1295432 PRODIGY AUTOCODE BLOOD GLUCOSE MONITORING DEVICE NBW OK BIOTECH CO., LTD. 51850 D190529-2 00384841518505

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR